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Completed

NCT Number: NCT06136117

Monkeypox, Biology, Outcome, Transmission and Epidemiology -Prospective Follow-up of High-risk Contacts

With the MBOTE-CONTACT study, a detailed follow-up study of high-risk contacts of mpox patients will be done. The MBOTE-CONTACT study will be nested in the NIH-Funded PALM-007 clinical trial (NCT05559099) and the MBOTE project on mpox transmission. The study will take place in Maniema Province, Democratic Republic of Congo (DRC). Participants will be recruited among high-risk contacts of mpox patients included in the PALM-007 trial. Consenting contacts will be either followed daily at the central study site or visited weekly by an outreach team in the community. They will be examined daily for signs and symptoms and asked to provide daily saliva and weekly blood samples for polymerase chain reaction (PCR) and/or serology. If participants develop mpox, they are offered treatment and enrollment in the PALM-007 trial.

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Key information

Conditions

Mpox Animal Diseases DNA Virus Infections Infections Mpox, Monkeypox Poxviridae Infections Primate Diseases Rodent Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Tunda

Tunda, Maniema Province, Democratic Republic of the Congo

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ▪ Be a high-risk contact of a laboratory-confirmed mpox case, with high-risk defined as having at least one the following types of exposure:
  • living in the same household as an mpox patient
  • having had sexual contact or intercourse with an mpox patient
  • sleeping in the same room as an mpox patient
  • sharing a meal with an mpox patient
  • children: having played together
  • Last exposure to the mpox index case of less than 14 days ago
  • Patients of any age and gender (children aged < 10 years are excluded from venous blood sampling)
  • Patient or culturally acceptable representative is willing and able to give informed consent for participation in the study

Exclusion criteria

  • Having previously been diagnosed with mpox in the last 3 months
  • Inability or unwillingness to comply with the proposed follow-up schedule

Treatment and study plan

Primary outcomes

  1. Study human-to-human transmission of Mpox virus (MPXV) by determining the secondary attack rate (SAR) among high-risk contacts of index patients.

    Time frame: 21 days

    Proportion of high-risk contacts with a positive MPXV PCR on any sample within 21 days after inclusion.

Secondary outcomes

  1. To determine the rate of seroconversion amongst high-risk contacts of index patients.

    Time frame: 21 days

    The proportion of high-risk contacts with seroconversion for mpox antibodies on day 21 compared to baseline.

  2. To estimate the extent of asymptomatic shedding of MPXV.

    Time frame: 21 days

    PCR positivity in any sample (blood, saliva) among participants who do not have any symptoms at the moment of sampling, but develop symptoms later during follow-up.

  3. To estimate the extent of presymptomatic shedding of MPXV.

    Time frame: 21 days

    PCR positivity in any sample (blood, saliva) among participants who do not have any symptoms at the moment of sampling, but develop symptoms later during follow-up.

  4. To estimate the duration between start of viral shedding and the appearance of prodromal symptoms.

    Time frame: 21 days

    Time between PCR positivity in any sample and appearance of systemic symptoms: either adenopathy, fever or dysphagia.

  5. To estimate the incubation period of MPXV.

    Time frame: 21 days

    Time from last exposure to first PCR positivity. Time from last exposure to appearance of any symptom. Time from last exposure to appearance of skin lesions.

  6. To characterize the clinical presentation of symptomatic secondary cases.

    Time frame: 21 days

    Frequency, timing and type of signs and symptoms observed among participants with a positive PCR.

  7. To evaluate risk factors for infection and/or symptomatic disease.

    Time frame: 21 days

    Number of contacts with positive PCR on any sample AND/OR symptomatic disease and one of the following factors:

    • Different types of contact with the index case
    • Exposure to the same animal reservoir as the index case
    • Being vaccinated against mpox
    • Sociodemographic factors

  8. To evaluate the protective effect of previous small pox vaccinations against infection and/or symptomatic disease.

    Time frame: 21 days

    number of previous vaccinate contacts positive PCR on any sample AND/OR symptomatic disease.

  9. To estimate the duration between start of viral shedding and the appearance of skin symptoms.

    Time frame: 21 days

    Time between PCR positivity in any sample and appearance of skin lesions.

Other outcomes

  1. To evaluate pre- or asymptomatic infectiousness.

    Time frame: 21 days

    Number of PCR-positive samples from which MPXV can be cultured in cell culture.

  2. To evaluate characteristics of the index cases that influence the risk of secondary infection.

    Time frame: 21 days

    Association between PCR positivity on any sample AND/OR symptomatic disease in the contact and characteristics of the index cases (included in PALM 007) including:

    • disease severity of the index case
    • site of PCR positivity of the index case
    • viral load in samples obtained from the index case

  3. To evaluate genomic differences in MPXV strains isolated from index and secondary cases

    Time frame: 21 days

    Whole genome sequencing of MPXV strains from index and secondary cases

Sponsors and collaborators

Lead sponsor

Institute of Tropical Medicine, Belgium

Other

Collaborators

  • Alliance for International Medical Action
  • Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
  • Institut de Recherche pour le Developpement
  • Leidos Biomedical Research, Inc.
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • University of California, Los Angeles
  • University of Manitoba

Registry information

Official study title

Mpox, Biology, Outcome, Transmission and Epidemiology - Prospective Follow-up of High-risk Contacts

Acronym: MBOTE-CONTACT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2023
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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